We are currently recruiting for a Change Control Specialist to join our Quality Assurance team. This role plays a critical part in ensuring the effective management and documentation of change control processes within a highly regulated medical device environment.
You will work collaboratively across multiple functions, supporting key quality processes and ensuring compliance with regulatory standards, company policies, and quality requirements.
Key Responsibilities
1. Maintain and support the change control process and associated documentation
2. Provide guidance and support to departments on developing and implementing change control plans
3. Support Quality Engineering activities across R&D, Manufacturing, Engineering and Quality functions
4. Prepare and maintain quality system documentation and records
5. Generate trending data and reports for management, regulatory bodies and customers
6. Drive continuous improvement of change control processes
7. Ensure compliance with Quality Management Systems and maintain audit readiness at all times
About You
You will have a strong background in Quality Assurance within a regulated environment, ideally within the medical device sector.
8. Degree in Science or Engineering (or equivalent experience)
9. Experience working within a Quality Management System in a regulated industry
10. Strong understanding of regulatory standards and QMS requirements
11. Excellent analytical, organisational and problem-solving skills
12. Strong communication and stakeholder management capability
13. Ability to manage priorities and meet deadlines in a fast-paced environment
14. Proficient with Microsoft Office and quality systems/tools
Why Join Us
At Terumo Aortic, you’ll be part of a collaborative and innovative organisation committed to improving patient outcomes worldwide. You will have the opportunity to work across global teams, contribute to meaningful change, and grow your career within a regulated and high-impact environment.